Evera S VRRecalls & reported problems across all models

We found 8 models of Evera S VR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 248 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 16, 2026 — classified as 3 deaths, 192 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (51 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Evera S VR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 10, 2023Open, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1800-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 10, 2023Open, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1799-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 3, 2021Open, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1305-2021 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

4. Dec 19, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0587-2018 · Root cause: Process design · names 3 of these models · Recall details · FDA record ↗

Most reported Evera S VR problems

Evera S VR models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Evera™ S VR DVBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls1 death120 reports
• Evera™ S VR DVBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls2 deaths100 reports
• Evera™ S VR DVBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall8 reports
• Evera™ S VR DVBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall8 reports
• Evera™ S VR DVBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall6 reports
• Evera™ S VR DVBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall2 reports
• Evera™ S VR DVBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 report
• Evera™ S VR DVBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  3 reports

Recent Evera S VR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received potential inappropriate therapy for Supra Ventricular Tachycardia (SVT), that the device d etected as Ventricular Tachycardia (VT). The Implantable Cardioverter Defibrillator (ICD) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50791544 ↗
• InjuryJun 25, 2026Delayed Charge Time

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED LOW VOLTAGE FRACTURE RESULTING IN THE PATIENT RECEIVING AN INAPPROPRIATE SHOCK. RV OVERSENSING, NOISE, AND OUT OF RANGE PACING IMPEDANCE WERE ALSO NOTED. ADDITIONALLY, A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALSO HAD A CHARGE CIRCUIT TIMEOUT. DETECTIONS WERE PROGRAMMED OFF. THE ICD AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626984 ↗
• MalfunctionMay 28, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE INCORRECT PHONE NUMBER WAS BEING CONTACTED WHEN THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS HAVING ISSUES. THE CONTACT INFORMATION WAS UPDATED. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319293 ↗
• InjuryApr 10, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840996 ↗
• InjuryFeb 24, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INITIALLY INAPPROPRIATELY WITHHELD THERAPY FOR A DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DUE TO WAVELET THAT WAS SUSPECTED VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24431352 ↗
• InjuryFeb 17, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A POTENTIAL DETECTION ISSUE IN WHICH AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24366139 ↗
• InjuryFeb 6, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IS COMPROMISED DUE TO MULTIPLE RV ELECTRODE FRACTURES AS A RESULT OF HIGH IMPEDANCE ALERTS. ADDITIONALLY, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279187 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24058908 ↗
• MalfunctionJan 12, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGE OUT THE DOCTOR WAS UNABLE TO LOOSEN THE SETSCREW. THE GROMMET WAS REMOVED AND THE AREA WAS FLUSHED WITH SALINE BUT THE SETSCREW WAS STILL UNABLE TO BE LOOSENED. A TORQUE WRENCH WAS ABLE TO FULLY ENGAGE TO THE SETSCREW BUT THE PHYSICIAN WAS UNABLE TO TURN COUNTERCLOCKWISE. THE PHYSICIAN STATED THEY BACKED THE SCREW ALL THE WAY OUT AT SOME POINT AND A TUG ON THE LEAD FREED FROM THE DEVICE. A CINE OF THE POCKET WAS PERFORMED TO BE SURE THE SCREW WAS NOT IN THE POCKET. NO SET SCREW WAS FOUND. THE ICD WAS SUCCESSFULLY REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049684 ↗
• InjuryJan 7, 2026Protective Measures Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992939 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 23569156 ↗
• InjuryOct 23, 2025Premature Discharge of Battery; Reset Problem; Premature Discharge of Battery; Reset Problem

  IT WAS REPORTED THAT THERE WAS MULTIPLE ELECTRICAL RESETS AND PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS ALSO NOTED THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION, "JUMPING OR TWITCHING IN THE CHEST," AND PALPITATIONS. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373821 ↗
• MalfunctionOct 16, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE BATTERY MEASUREMENT WENT "DOWN AND THEN BACK UP." THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310721 ↗
• InjuryOct 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) DUE TO PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE ICD COULD NOT BE INTERROGATED DUE THE A DEAD BATTERY. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285550 ↗
• MalfunctionSep 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD¿S SENSING INTEGRITY COUNTER (SIC) WAS ELEVATED. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088968 ↗

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